Entifenazine 5 mg (Solasulfone)

Adult dose

The usual recommended dose for adults (including the elderly) is 5mg once daily. If necessary, the dose may be increased to a maximum of 10mg once daily. This medicine may be taken with or without food; swallow it whole with water. Dosage adjustment is necessary for the following patients. 1. Patients with renal impairment: No dose adjustment is necessary for patients with mild or moderate renal impairment (creatinine clearance>30ml/min). Use caution in patients with severe renal impairment (creatinine clearance≤30ml/min), and do not exceed 5mg once daily. 2. Patients with hepatic impairment: No dose adjustment is necessary for patients with mild hepatic impairment. Use caution in patients with moderate hepatic impairment (Child-Pugh Class B), and do not exceed 5mg once daily. 3. Patients receiving potent cytochrome P450 3A4 (CYP3A4) inhibitors: Limit the maximum daily dose to 5mg in patients receiving ketoconazole or another potent CYP3A4 inhibitor (e.g., ritonavir, nelfinavir, itraconazole).

This drug should not be used in patients with urinary retention symptoms, severe gastrointestinal diseases, myasthenia gravis, or angle-closure glaucoma. In addition, it should not be administered to patients with allergies to this drug or its components, those undergoing hemodialysis, or patients with severe liver or kidney impairment. Caution is required in patients at risk of urinary retention or those with gastrointestinal obstructive diseases or risk of decreased gastrointestinal motility. In patients with renal or hepatic dysfunction, the dosage should be limited, and caution is also needed when taken in conjunction with certain potent drugs. Taking this medication may lead to side effects such as dry mouth, constipation, blurred vision, urinary retention, dry eyes, etc., with dry mouth and constipation being the most common. In severe cases, serious allergic reactions such as bowel obstruction or angioedema, anaphylaxis may occur, and if such symptoms arise, immediate discontinuation of the drug and medical treatment should be sought. This medication may require caution when driving or operating machinery due to potential drowsiness or blurred vision. When taken with other anticholinergic drugs, effects may be enhanced or side effects may be exacerbated, so consultation with a professional is necessary. This drug is metabolized by specific enzymes in the liver, necessitating a dose adjustment when taken with other drugs that inhibit this enzymatic activity. For pregnant women, caution is essential as the safety of this drug has not been established, and for nursing mothers, it is advisable to avoid use as it may be transmitted through breast milk. In children, the safety and effectiveness of this drug have not been confirmed, so it should not be used. In cases of overdose, symptoms such as headache, dizziness, drowsiness, and blurred vision may occur, and in severe cases, professional treatment may be necessary. Before taking this medication, it is essential to check for risk factors for QT prolongation such as heart disease or electrolyte abnormalities, and these patients require special caution.

• dry mouth
• constipation
• blurred vision
• urinary retention
• dry eyes
• bowel obstruction
• colonic obstruction
• intestinal obstruction
• angioedema
• nausea

This drug should be stored in a tightly closed container to prevent air or moisture from entering and should be kept in a cool room temperature between 1 and 30 degrees Celsius. This will help maintain the drug's effectiveness for a longer period.

Appearance

Bright yellow round film-coated tablet

Package unit

100 tablets/PTP [(10 tablets/PTP package x 10)], 30 tablets/bottle, 100 tablets/bottle